Shoulder Implant For Simulating A Bursa

ABSTRACT

A shoulder implant for simulating a naturally occurring bursa proximal to or in lieu of a subacromial bursa, the shoulder implant comprising: an expandable member expandable to a size and/or a shape sufficient to fill a space beneath an acromion and/or a coracoid process of the shoulder, the space defines a filled volume less than a maximal volume occupied by the expandable member if fully expanded; and an amount of filler for filling the expandable member to the filled volume, such that, when implanted, the expandable member is configured to cushion and facilitate motion between a tendon and/or ligament of a rotator cuff, and a bone part in the shoulder.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/305,311 filed on Jun. 16, 2014, which is a continuation of U.S.patent application Ser. No. 12/531,332 filed on Sep. 15, 2009, which isa National Phase of PCT Patent Application No. PCT/IL2008/000347 havingInternational filing date of Mar. 13, 2008, which claims the benefit ofpriority of U.S. Provisional Patent Application No. 60/918,051 filed onMar. 15, 2007. The contents of the above applications are allincorporated herein by reference.

FIELD OF INVENTION

The present inventions relate generally to the field of medical devicesand the treatment of human medical conditions using the medical devices.More specifically, the present inventions include expandable prostheticdevices used for treating a variety of conditions, including rotatorcuff injuries, broken and/or depressed bone fractures, infection and/orinflammation in the body.

BACKGROUND OF THE INVENTION

Through repeated strenuous motion, sensitive soft tissues often sufferwear and tear injuries from repeatedly rubbing against one anotherand/or hard tissues, such as bone. Tears of rotator cuff tendons andarticular capsule disintegration are examples of this type of injury. Inaddition, these tissues can be adversely affected by inflammation,infection, disease and/or genetic predispositions which lead todegeneration of these tissues.

Other bodily injuries, such as fractures of hollow bones (i.e. havingmedullar cavities) and depression fractures of vertebra require complexprocedures for treatment, for example alignment and fixation of multiplebone fragments for the former and disc replacement for the latter.

Various solutions to problems in treatment of these injuries have beenproposed, for example:

U.S. Pat. App. Pub. No. 2007/0198022 to Lang, et al., the disclosure ofwhich is incorporated herein by reference, describes methods,compositions and tools for repairing articular surfaces repair materialsand for repairing an articular surface. The articular surface repairsare customizable or highly selectable by patient and geared towardproviding optimal fit and function. The surgical tools are designed tobe customizable or highly selectable by patient to increase the speed,accuracy and simplicity of performing total or partial arthroplasty.

JP Pat. App. Pub. No. 2006-247257 to Yasuhiko, et al., the disclosure ofwhich is incorporated herein by reference, describes a bone cementinjector which is equipped with an injection tube and a balloondetachably mounted on one end of the injection tube, where the balloonis formed with a bioabsorptive material. Using the bone cement injectorof this invention, the balloon is inserted into the damaged section ofthe vertebra to be treated, and subsequently the bone cement is injectedinto this balloon. Thereby, the bone cement can be injected into thecorpus vertebra of the damaged part of the vertebra while preventing theblood from mixing in the bone cement and the bone cement from leakinginto the vertebral canal.

U.S. Pat. App. Pub. No. 2005/0245938 to Kochan, the disclosure of whichis incorporated herein by reference, describes a device for repair ofintervertebral discs and cartilages in articular joints includes acatheter for inserting through a cannula, the catheter having a distalend and a proximal end and a lumen extending longitudinallytherethrough. An expandable balloon may optionally be detachablyattached to the catheter near the distal end. The proximal end of thecatheter is coupled to an injector that holds a supply of athermoplastic elastomer material at a predetermined elevated temperaturesufficiently high to maintain the thermoplastic elastomer at a liquidstate. The device allows a thermoplastic elastomer material to beinjected into the intervertegral disc space or the articular joint spaceas a replacement prosthetic for the disc's nucleus pulposus or thejoint's cartilage. This procedure is carried out percutaneously throughthe cannula.

U.S. Pat. No. 6,755,862 to Keynan, the disclosure of which isincorporated herein by reference, describes an intramedullary supportstrut for a long bone for a range of different applications includinganchoring and fixation. The strut is in the form of nested telescopicmembers. In the retracted configuration, the strut is compact and may beinserted into position aligned with a shaft made in the medullary canalvia a portal made in the lateral cortex of the bone. The strut may thenbe telescopically extended into the medullary canal to provide therequired support.

U.S. Pat. No. 6,613,052 to Kinnett, the disclosure of which isincorporated herein by reference, describes an apparatus developed toenable a surgeon to perform multiple orthopedic surgical operations,such as orthopedic surgical resectioning, total joint replacement andfixation of fractures, based on a single reference point. The apparatusis adjustable to conform to the needs and dimensions of individualpatients and the surgical procedure(s) to be performed. The apparatusincludes a support adapted for insertion into and alignment within themedullary cavity of a patient's bone. The support is capable ofexpanding into the bone so that the support is fixed within the bone andalignable to the bone. The support may be implanted to align a fracturedbone, or extend a distance beyond its fixed position within themedullary cavity to provide a known surgical reference point. Theapparatus includes one or more cutting guides mountable on the supportand used in performing the desired surgical procedure(s). The cuttingguides are positionable with respect to the known surgical referencepoint created by the support which enables the user to accuratelyposition and secure various instruments at the desired position aboutthe patient's anatomy.

SUMMARY OF THE INVENTION

An aspect of some embodiments of the invention relates to prosthesesadapted to reduce injuries between soft tissues of the body and othertissues. In an embodiment of the invention, soft tissues are forexample, tendons and/or ligaments. In an embodiment of the invention,other tissues are, for example, bones. In an embodiment of theinvention, the prosthesis is expandable. Optionally, the prosthesis iselastic. In some embodiments of the invention, the prosthesis is rigid.In an embodiment of the invention, the prosthesis is shaped and/or sizedto simulate a bursa naturally occurring in the body. Optionally, thebursa simulated is the one expected to be present at the implantationsite of the prosthesis in a healthy patient.

In an embodiment of the invention, an expandable prosthesis adapted toreduce and/or eliminate injury to the rotator cuff. Optionally, theexpandable prosthesis is sponge-like. Optionally, the expandableprosthesis is inflatable. In some exemplary embodiments of theinvention, the expandable prosthesis is adapted to be inserted betweenthe tendons of the rotator cuff and the acromion and/or coracoidprocess. Expandable prosthesis is biocompatible and/or biodegradable, inan exemplary embodiment of the invention. Optionally, the expandableprosthesis is adapted to elute pharmaceutical agents once implanted in apatient's body. In an embodiment of the invention, inflatable expandableprosthesis is inflated with filler, for example a gas, liquid, and/orgel. Optionally, the filler is biocompatible and/or biodegradable. Insome embodiments of the invention, the prosthesis is only partiallyfilled.

In some embodiments of the invention, the prosthesis is provided withanchoring devices adapted to maintain the prosthesis in a steadyrelationship with the anatomical features around the implantation site.Optionally, the prosthesis is contoured along its exterior toaccommodate anatomical features around the implantation site.

An aspect of some embodiments of the invention relates to a method forimplanting an expandable prosthesis adapted to reduce and/or eliminateinjury between soft tissues of the body and other tissues, for exampleto the rotator cuff. In an embodiment of the invention, the expandableprosthesis is either sponge-like or inflatable and is expanded in aspace between the tendons of the rotator cuff and the acromion and/orcoracoid process. In some embodiments of the invention, a prosthesisimplantation and/or inflation device is used to implant and/or inflatethe expandable prosthesis.

An aspect of some embodiments of the invention relates to an expandableprosthesis for the alignment of bone fragments which is provided withwalls thick enough to withstand the stresses of normal activity whilestill maintaining the bone fragments in alignment. In an embodiment ofthe invention, the expandable prosthesis is inflatable. In someexemplary embodiments of the invention, the expandable prosthesis isadapted to be inserted into the medullar cavity of a plurality of bonefragments. Expandable prosthesis is biocompatible and/or biodegradable,in an exemplary embodiment of the invention. Optionally, the expandableprosthesis is adapted to elute pharmaceutical agents once implanted in apatient's body. In an embodiment of the invention, inflatable expandableprosthesis is inflated with filler, for example a gas, liquid, cementand/or gel, to provide sufficient rigidity to expandable prosthesis toalign a plurality of bone fragments. Optionally, the filler isbiocompatible and/or biodegradable.

In some embodiments of the invention, the prosthesis is provided with acalibration kit which is designed to determine the size and/or shape ofthe medullar cavity of the bone fragments and/or to choose anappropriate sized prosthesis for implantation into the cavity.

An aspect of some embodiments of the invention relates to a method foraligning bone fragments using an inflatable, expandable prosthesis. Inan embodiment of the invention, an inflatable, expandable prosthesis isintroduced into the medullar channel of a plurality of bone fragments.In some embodiments of the invention, a prosthesis implantation and/orinflation device is used to implant and/or inflate the expandableprosthesis. Optionally, pharmaceutical agents are eluted into thepatient by the expandable prosthesis.

An aspect of some embodiments of the invention relates to an expandableprosthesis for treating inflammation and/or infection. Optionally, theexpandable prosthesis is a sponge-like structure, sponge-like beingdefined as including at least one of the following properties: porous,absorbent and/or compressible. Optionally, the expandable prosthesis isinflatable. Expandable prosthesis is biocompatible and/or biodegradable,in an exemplary embodiment of the invention. Optionally, the expandableprosthesis is adapted to elute pharmaceutical agents once implanted in apatient's body. Expandable sponge-like device optionally contains withinits cavities at least one biocompatible and/or biodegradable gellingmaterial that expands when it comes into contact with at least onebodily fluid, for example by absorbing water.

In an embodiment of the invention, inflatable expandable prosthesis isinflated with filler, for example a gas, liquid, and/or gel. Optionally,the filler is biocompatible and/or biodegradable and/or contains thepharmaceutical agents. In some embodiments, elution of pharmaceuticalagents is according to a schedule timed with the biodegradableproperties of the expandable prosthesis.

An aspect of some embodiments of the invention, relates to an expandableprosthesis for treating depressed fractures. In some embodiments of theinvention, the expandable prosthesis comprises an inner section and anexternal section. Optionally, at least one section of the expandableprosthesis is sponge-like. The at least one sponge-like sectionoptionally contains within its cavities at least one biocompatibleand/or biodegradable gelling material that expands when it comes intocontact with at least one bodily fluid, for example by absorbing water.Optionally, at least one section of the expandable prosthesis isinflatable. In an embodiment of the invention, the at least oneinflatable expandable section is inflated with filler, for example agas, liquid, cement and/or gel, to provide sufficient rigidity to treatthe depressed fracture.

In some exemplary embodiments of the invention, the expandableprosthesis is adapted to be inserted at or near a fractured vertebra.Expandable prosthesis is optionally biocompatible and/or biodegradable,in an exemplary embodiment of the invention. Optionally, the expandableprosthesis is adapted to elute pharmaceutical agents once implanted in apatient's body.

In an embodiment of the invention, at least one section of theprosthesis is inflated with filler, for example a gas, liquid, cementand/or gel. Optionally, the filler is biocompatible and/orbiodegradable. In some embodiments of the invention, the expandableprosthesis is adapted to have at least one section removed prior toclosing the patient. In an embodiment of the invention, at least onesection is adapted to withstand the expected pressures from beingimplanted at or near a vertebra of the patient. In an embodiment of theinvention, the expandable prosthesis is inflated and/or implanted usinga plurality of prosthesis inflation and/or implantation devices.

An aspect of some embodiments of the invention relates to a method fortreating depressed fractures using an expandable prosthesis. In anembodiment of the invention, the method implants at least one section ofan expandable prosthesis comprising a plurality of separately expandableand/or retractable sections. In an embodiment of the invention, at leastone section of an expandable prosthesis is used to properly deployfiller for treating the depressed fracture. Optionally, at least onesection of the expandable prosthesis is withdrawn from the patientbefore closing the patient. Optionally, at least one section of theexpandable prosthesis is sealed and implanted in the patient. In someembodiments of the invention, pharmaceutical agents are eluted into thepatient by the expandable prosthesis.

An aspect of some embodiments of the invention relates to a prosthesisimplantation and/or inflation device. In an embodiment of the invention,the prosthesis implantation and/or inflation device includes a syringeadapted to inject filler into an expandable prosthesis, for examplethrough a tube which operatively connects syringe to the expandableprosthesis. In some embodiments of the invention, the syringe iscomprised of at least a plunger and a canister. Optionally, the plungeris advanced through the canister by the device in order to inject fillerinto the prosthesis. Optionally, the canister is advanced against theplunger, which remains relatively fixed due to counterforce from abackstop, in order to inject filler into the prosthesis.

In some exemplary embodiments of the invention, the prosthesisimplantation and/or inflation device includes a safety. Optionally, thesafety comprises at least a spring and a ball, wherein the ball acts asa counterpart to a groove in the backstop. Excessive force on thebackstop by continued advancement of the canister towards the plungertriggers the safety, popping the ball out of the groove and freeing thebackstop to move. In an embodiment of the invention, the placement ofthe backstop is according to a predetermined level of desired inflationof the prosthesis.

There is thus provided in accordance with an embodiment of theinvention, a prosthesis for reducing injury to soft tissues of the body,comprising: a member adapted to simulate at least one of a size or ashape of a naturally occurring bursa.

In an embodiment of the invention, the member is expandable. Optionally,the member is adapted to be at least partially inflated. Optionally, themember is inflated sufficiently to reduce rubbing of the soft tissuesagainst other tissues while permitting at least some movement of thesoft tissues relative to the other tissues. Optionally, at least somemovement of the soft tissues relative to the other tissues is fullmovement. In an embodiment of the invention, the member is sponge-like.Optionally, the sponge-like member is provided with a fluid absorbentmaterial which when fluids are absorbed induces expansion of thesponge-like expandable member.

In an embodiment of the invention, the prosthesis is constructed of atleast one of a biocompatible or biodegradable material. Optionally, theat least one of a biocompatible or biodegradable material is PCL, PGA,PHB, plastarch material, PEEK, zein, PLA, PDO, PLGA, collagen or methylcellulose.

In an embodiment of the invention, the prosthesis is constructed of atleast one non-biodegradable material. Optionally, the at least onenon-biodegradable material is polyethylene, polyurethane, silicon, orpoly-paraphenylene terephthalamide.

In an embodiment of the invention, the prosthesis further comprises arigid ring having a lumen therein attached to the member, wherein thelumen provides fluid communication to an inner space of the member.

In an embodiment of the invention, the prosthesis further comprises aplug adapted to lodge in the lumen thereby sealing the inner space ofthe member. Optionally, the plug is constructed of at least one of abiocompatible or biodegradable material.

In an embodiment of the invention, the member is elastic.

In an embodiment of the invention, the prosthesis further comprises atleast one anchoring device for stabilizing the prosthesis uponimplantation. Optionally, the at least one anchoring device isconstructed of at least one of a biocompatible or biodegradablematerial.

In an embodiment of the invention, the member is contoured to act as acounterpart to natural anatomical features of an implantation site.

In an embodiment of the invention, adapted to elute at least onepharmaceutical agent.

In an embodiment of the invention, the size of the prosthesis isapproximately 2 cm to 10 cm in length along a long axis, approximately 2cm to 7 cm in length along a short axis and approximately 0.5 mm to 20mm in height, when expanded.

In an embodiment of the invention, the member is rigid. Optionally, themember is contoured to act as a counterpart to natural anatomicalfeatures of an implantation site while permitting at least some movementof the soft tissues relative to other tissues.

In an embodiment of the invention, adapted for reducing injury to arotator cuff. In an embodiment of the invention, adapted for reducinginjury to at least one of a flexor or an extensor. In an embodiment ofthe invention, adapted for reducing injury between a quadriceps and afemur. In an embodiment of the invention, adapted for reducing injurybetween a skin and a plantar fascia and a calcaneus of the body. In anembodiment of the invention, injury is at least one of inflammation orinfection.

There is further provided in accordance with an exemplary embodiment ofthe invention, a method for implanting a prosthesis adapted to reduceinjury to between soft tissues and other tissues of a body, comprising:placing the prosthesis into an implantation site between the softtissues and the other tissues; and, simulating with the prosthesis abursa naturally occurring at the implantation site. In an embodiment ofthe invention, the method further comprises eluting at least onepharmaceutical agent from the prosthesis at the implantation site.Optionally, placing and simulating occurs without significantly reducingmovement of the soft tissues relative to the other tissues. Optionally,the soft tissues are tendons of a rotator cuff and the other tissues areat least one of a humerus, an acromion or a coracoid process.

There is further provided in accordance with an exemplary embodiment ofthe invention, a prosthesis for the alignment of bone fragments,comprising: a member adapted to be implanted in the medullar cavity ofthe bone fragments, wherein the member is provided with an outer wallthickness adapted to accommodate at least a minimum level of rigiditynecessary to maintain bone fragment alignment during normal activity. Inan embodiment of the invention, the prosthesis further comprises acalibration kit adapted to perform at least one of determining the sizeof the medullar cavity or introducing the proper sized member into themedullar cavity. Optionally, the member is tubular or vasiform in shape.Optionally, at least the member is constructed of at least one of abiocompatible or biodegradable material. Optionally, the member has anapproximate outer diameter between 2 mm and 15 mm and an approximatelength between 5 cm and 50 cm. Optionally, the prosthesis is adapted toelute at least one pharmaceutical agent.

There is further provided in accordance with an exemplary embodiment ofthe invention, a method for aligning bone fragments, comprising:introducing a prosthesis into the medullar cavity of a plurality of bonefragments; and, inflating the prosthesis to a sufficient rigidity tohold the bone fragments in alignment during normal activity. In anembodiment of the invention, the method further comprises determiningthe size of the medullar cavity using a calibration kit.

There is further provided in accordance with an exemplary embodiment ofthe invention, a prosthesis adapted for treating depressed fracturescomprising a plurality of separately expandable and retractablesections. Optionally, the prosthesis comprises an inner section and anouter section, wherein the outer section at least partially surroundsthe inner section. Optionally, the inner section is cylindrical andmeasures approximately 2 cm to 7 cm in diameter and 2 cm to 5 cm inheight. Optionally, the inner section and outer section are manufacturedfrom at least one of polyurethane, ultra high molecular weightpolyethylene, poly-paraphenylene terephthalamide, PCL, PGA, PHB,plastarch material, PEEK, zein, PLA, PDO and PLGA, collagen, or methylcellulose.

There is further provided in accordance with an exemplary embodiment ofthe invention, a method for treating a depressed fracture using aprosthesis comprising a plurality of separately expandable andretractable sections, comprising: introducing the prosthesis to theimplantation area, wherein the fracture is concave in relation to thearea; inflating an inner section; inflating an outer section; deflatingthe inner section; and, filling a cavity left by the deflating of theinner section such that support is rendered to the depressed fracturefrom the filled cavity. Optionally, the inner section is withdrawn priorto filling the cavity.

In an embodiment of the invention, the method further compriseswithdrawing the outer section after filling the cavity.

There is further provided in accordance with an exemplary embodiment ofthe invention, a system for sealing an inflatable prosthesis,comprising: a prosthesis inflation device; a tube operatively connectedto the prosthesis near one end and the prosthesis inflation device onthe other end; a plug attached to the tube at the prosthesis end of thetube; and, a rigid ring attached to the prosthesis and slidably attachedaround the tube between the prosthesis inflation device and the plug;wherein pulling the tube towards the prosthesis inflation device causesplug to lodge in the rigid ring, sealing the prosthesis with the plug.Optionally, the plug is attached to the tube by gripping protrusions.

There is further provided in accordance with an exemplary embodiment ofthe invention, a method of sealing an inflatable prosthesis, comprising:pulling a tube out of the prosthesis and through a rigid ring; and,lodging a plug located on the end of the tube in the rigid ring.

BRIEF DESCRIPTION OF THE FIGURES

Non-limiting embodiments of the invention will be described withreference to the following description of exemplary embodiments, inconjunction with the figures. The figures are generally not shown toscale and any measurements are only meant to be exemplary and notnecessarily limiting. In the figures, identical structures, elements orparts which appear in more than one figure are preferably labeled with asame or similar number in all the figures in which they appear, inwhich:

FIG. 1 is an illustration of a sponge-like expandable prosthesis adaptedto reduce and/or eliminate injury to the rotator cuff, in accordancewith an exemplary embodiment of the invention;

FIG. 2 is a cutaway view of a portion of a prosthesis implantationand/or inflation device and an inflatable expandable prosthesis adaptedto reduce and/or eliminate injury to the rotator cuff, in accordancewith an exemplary embodiment of the invention;

FIG. 3 is an anatomical view of a human shoulder with an expandableprosthesis in vivo, in accordance with an exemplary embodiment of theinvention;

FIGS. 4A-C are cutaway side views showing the progression removablyattaching a prosthesis implantation and/or inflation device and anexpandable prosthesis, in accordance with an exemplary embodiment of theinvention;

FIG. 5 is a cutaway side view of a portion of a prosthesis implantationand/or inflation device including a counter-pressure sheath and anexpandable prosthesis, in accordance with an exemplary embodiment of theinvention;

FIG. 6 is a cutaway side view of an alternative sealing mechanism, inaccordance with an exemplary embodiment of the invention;

FIG. 7 is a flowchart demonstrating a method of implanting an expandableprosthesis, in some exemplary embodiments of the invention;

FIG. 8 is a cutaway side view of an expandable prosthesis packed priorto use, in accordance with an exemplary embodiment of the invention;

FIG. 9 is a cutaway side view of a portion of a prosthesis implantationand/or inflation device and an expandable prosthesis for alignment ofbone fragments, in accordance with an exemplary embodiment of theinvention;

FIG. 10 is a flowchart showing a method of aligning two or more segmentsof bone, in accordance with an exemplary embodiment of the invention;

FIG. 11 is a cutaway side view of an expandable prosthesis for aligningbone fragments in vivo, in accordance with an exemplary embodiment ofthe invention;

FIG. 12 is a perspective view of a device for treating inflammationand/or infection, in accordance with an exemplary embodiment of theinvention;

FIG. 13 is a perspective view of a device for treating depressedfractures, in accordance with an exemplary embodiment of the invention;

FIG. 14 is a perspective view, with a cutaway side view of twovertebrae, of a device for treating depressed fractures of vertebrae, inaccordance with an embodiment of the invention;

FIG. 15 is a flowchart showing a method of treating depressed fractures,in accordance with an exemplary embodiment of the invention;

FIG. 16 is a cutaway side view of a prosthetic inflation device, inaccordance with an exemplary embodiment of the invention; and,

FIG. 17 is a cutaway side view of an alternate prosthetic inflationdevice, in accordance with an exemplary embodiment of the invention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

As described above, repeated strenuous motion often causes sensitivesoft tissues to suffer wear and tear injuries from repeatedly rubbingagainst one another and/or hard tissues, such as bone. Tears of tendonsand/or ligaments and articular capsule disintegration are examples ofthis type of injury. In addition, these tissues can be adverselyaffected by inflammation, infection, disease and/or geneticpredispositions which lead to degeneration of these tissues.

Injuries to soft tissues such as tendons can cause pain and impairedfunction of the area served by the tendon. Typically, a bursa can befound near areas where “friction” injuries due to the rubbing are proneto occur. A bursa is a natural fluid collection that permits movementsbetween tendons and/or ligaments and bone parts and prevents injury tothese tendons by acting as a cushion and/or movement facilitator betweenthem.

In some embodiments of the invention, prostheses described herein areshaped and/or sized to simulate the natural bursa found in the intendedarea of implantation. For example, in some of the rotator cuffembodiments described below, the described exemplary prostheses areshaped and/or sized to simulate the subacromial bursa. Optionally, theprostheses are sized to supplement a natural bursa which is misshapenand/or undersized, bringing the combination of the natural bursa and theprosthesis into line with the shape and/or size of a healthy bursa.

The rotator cuff is an anatomical term given to the group of muscles andtheir tendons that act to stabilize the shoulder and to permit rotationand abduction of the arm. Along with the teres major and the deltoid,the four muscles of the rotator cuff make up the six muscles of thehuman body which connect to the humerus and scapula. Injury to thetendons and/or these muscles can cause pain and impaired function of theshoulder. The subacromial bursa is a natural fluid collection thatpermits movement of these rotator cuff tendons beneath the acromion andcoracoid process, both of which are part of scapula bone. In somerotator cuff injuries, the subacromial bursa becomes inflamed andsuffers from a reduced ability to prevent injury to the tendons throughfriction.

Referring to FIG. 1, an expandable prosthesis 100 is shown which isadapted to reduce and/or eliminate injury to the rotator cuff, in anexemplary embodiment of the invention. In an exemplary embodiment of theinvention, expandable prosthesis 100 is introduced between the abovementioned acromion and coracoid processes and the rotator cuff tendonsto prevent continued injury to these body parts and/or to permitrelatively unhindered (relative to the movement afforded to the shoulderwithout treatment) or free shoulder movement, shown and described inmore detail with respect to FIG. 3. In some embodiments of theinvention, expandable prosthesis 100 comprises an expandable memberwhich is a sponge-like structure. It should also be understood thatsponge-like expandable prosthesis 100 is adapted to elutepharmacological substances such as anti-inflammatory and/or antibioticand/or pro-angiogenesis substances, in some exemplary embodiments of theinvention.

In an exemplary embodiment of the invention, sponge-like expandableprosthesis 100 is biodegradable and/or biocompatible. The sponge-likestructure is manufactured from at least one biodegradable and/orbiocompatible synthetic material such as, but not limited to,polycaprolactone (“PCL”), polyglycolide (“PGA”), polyhydroxybutyrate(“PHB”), plastarch material, polyetheretherketone (“PEEK”), zein,polylactic acid (“PLA”), polydioxanone (“PDO”) andpoly(lactic-co-glycolic acid) (“PLGA”), or any combination and/or familymembers thereof. In some exemplary embodiments of the invention, thesponge-like structure is manufactured from at least one“naturally-derived” biodegradable and/or biocompatible materials such ascollagen and/or methyl cellulose. In an exemplary embodiment of theinvention, sponge-like expandable prosthesis 100 is imparted expandableproperties, at least in part, by placing within its cavities at leastone biocompatible and/or biodegradable material which expands aftercoming into contact with fluids. Optionally, the fluids are bodilyfluids. Optionally, the at least one biocompatible and/or biodegradablematerial is a gel.

In some exemplary embodiments of the invention, sponge-like expandableprosthesis 100 is non-biodegradable. Non-biodegradable expandableprostheses are manufactured of biocompatible materials such aspolyethylene, Kevlar® (poly-paraphenylene terephthalamide), polyurethaneor silicon, or any combination thereof, in some embodiments of theinvention. In some exemplary embodiments of the invention, theexpandable prosthesis is manufactured from biologically derived,biocompatible and/or biodegradable materials such as collagen. In anexemplary embodiment of the invention, prosthesis 100, when expanded,has approximately the same dimensions as other prostheses when expanded,described below.

Referring to FIG. 2, a cutaway view of a portion of a prosthesisimplantation and/or inflation device 200 and a prosthesis 202 with anexpandable member which is inflatable is shown, in accordance with anexemplary embodiment of the invention. Exemplary embodiments ofprosthesis implantation and/or inflation device 200 are described inmore detail with respect to FIGS. 16-17. In an exemplary embodiment ofthe invention, inflatable expandable prosthesis 202 is introducedbetween the above mentioned acromion and coracoid processes and therotator cuff tendons to prevent continued injury to these body partsand/or to permit relatively unhindered or free shoulder movement, shownand described in more detail with respect to FIG. 3. Optionally,alternatively and/or additionally, an expandable prosthesis comprises aninflatable structure and a sponge-like structure in combination.

In an exemplary embodiment of the invention, inflatable expandableprosthesis 202 is rectangular shaped when deflated and resembles acuboid parallelepiped when inflated. In an exemplary embodiment of theinvention, inflatable expandable prosthesis 202 is circular or oval inshape when deflated and when inflated resembles a cylindrical disc orovoid. It should be understood, however, that many shapes could beadapted to be implanted between the acromion and coracoid processes andthe rotator cuff tendons to prevent at least some injury to the rotatorcuff and/or to permit relatively unhindered or free shoulder movementfor a patient, in an exemplary embodiment of the invention. In someembodiments of the invention, prosthesis 202 is adapted to be inserteddeflated into a patient's body through a cannula. Optionally, thecannula is a 5 mm-7 mm cannula. In an embodiment of the invention, along axis 204 (x-axis) of inflatable expandable prosthesis 202 isapproximately 2 cm to 10 cm in length when inflated. In some embodimentsof the invention, a short axis 208 (y-axis) of inflatable expandableprosthesis 202 is approximately 2 cm to 7 cm in length when inflated Insome exemplary embodiments of the invention, inflatable expandableprosthesis 202 is 0.5 mm to 20 mm in height (z-axis). Optionally,inflatable expandable prosthesis 202 is 1 mm to 10 mm in height. Itshould be understood that the deflated and/or inflated size ofprosthesis 202 is adapted to fit for a patient's particular needs or tosimulate the size and/or shape of the natural bursa, in an embodiment ofthe invention, and therefore, prosthesis 202 does not necessarilyconform to the size ranges given above.

Inflatable expandable prosthesis 202 is manufactured by dip molding, inan exemplary embodiment of the invention. In some embodiments of theinvention, inflatable expandable prosthesis 202 is a seamlessballoon-like structure made from biocompatible and/or biodegradablesynthetic materials such as, but not limited to, PCL, PGA, PHB,plastarch material, PEEK, zein, PLA, PDO and PLGA, or any combinationand/or family members thereof. Additionally, optionally and/oralternatively, inflatable expandable prosthesis 202 is manufactured fromnatural, biocompatible and/or biodegradable materials such as collagenand/or methyl cellulose. In some exemplary embodiments of the invention,the inflatable prosthesis 202 is manufactured from at least onenon-biodegradable material such polyethylene, polyurethane, silicon,and/or Kevlar®. In an embodiment of the invention, prosthesis 202 iscomprised of a material which is approximately 100 microns in thickness,although, as with the other dimensions, the thickness dimension of thematerial is adapted depending on the intended use and/or the needs ofthe patient. In some exemplary embodiments of the invention, inflatableexpandable prosthesis 202 is adapted to elute pharmaceuticals such asanti-inflammatory drugs and/or antibiotics and/or pro-angiogenesisfactors to promote healing.

Inflatable expandable prosthesis 202 is releasably attached toprosthesis implantation and/or inflation device 200, in an exemplaryembodiment of the invention. Prosthesis implantation and/or inflationdevice 200 is adapted to inflate and/or deflate prosthesis 202, allowprosthesis 202 to be positioned in vivo, and/or separate from prosthesis202 after implantation, leaving prosthesis 202 at the implantation site,in an embodiment of the invention. In some exemplary embodiments of theinvention, prosthesis implantation and/or inflation device 200 includesa tube or catheter type structure 204 which interfaces with prosthesis202 in the proximity of a sealing mechanism 206 which is located at theend of tube 204 nearest prosthesis 202.

In an embodiment of the invention, sealing mechanism 206 includes a plug402, shown in FIG. 4B inter alia, attached to the end of tube 204nearest prosthesis 202. In an embodiment of the invention, plug 402 isconstructed of the same material or materials as any of the prosthesesdescribed herein. Tube 204 is adapted to allow passage therethrough ofthe substance used to fill prosthesis 202, for example by placing atleast one orifice 404 in tube 204. In some embodiments of the invention,air is used to inflate prosthesis 204. Additionally, alternativelyand/or optionally, a biodegradable and/or biocompatible substance isused to inflate prosthesis 202. In some embodiments of the invention, agel or liquid is used to inflate prosthesis 202. In an embodiment of theinvention, tube 204 is provided with gripping protrusions 406 in orderto increase the contact surface between tube 204 and plug 402 andtherefore the force that may be applied to plug 402 when sealingprosthesis 202. In some embodiments of the invention, plug 402 is ovoidshaped, and/or has a shape such that plug's 402 loose end 408 is largerthan the attached end 410 so that, as described in more detail belowwith respect to FIGS. 4A-C, 5 and 7, plug 402 seals inflatableexpandable prosthesis 202 during implantation.

FIGS. 4A-C are cutaway side views showing the progression of removablyattaching prosthesis implantation and/or inflation device 200 andprosthesis 202, in accordance with an exemplary embodiment of theinvention. Referring to FIG. 4A, a rigid ring 412 is cast on tube 204 ofprosthesis implantation and/or inflation device 200, in an embodiment ofthe invention. In an embodiment of the invention, rigid ring 412 fitssnugly onto tube 204 such that air and/or other fluid injected intoprosthesis 202 does not escape via the intersection of rigid ring 412and tube 204, however tube 204 is slidable in relation to rigid ring412. This slidability is useful, for example, when prosthesisimplantation and/or inflation device 200 is separated from prosthesis202 in accordance with an exemplary embodiment of the invention. In anexemplary embodiment of the invention, plug 402 is cast on tube 204 suchthat gripping protrusions 406 grasp at least a portion of attached end410 of plug 402, shown in FIG. 4B. Optionally, dip molding, or any othermethod known in the art, is used for manufacturing plug. At least tube204 and/or plug 402 and/or rigid ring 412 are made of biodegradableand/or biocompatible materials, in an embodiment of the invention.

Rigid ring 412 is cast on tube 204 before plug 402 is cast tube 204because in an exemplary embodiment of the invention, plug 402 has alarger diameter than the inner diameter of rigid ring 412 therebypreventing plug 402 from passing through rigid ring 412. In anembodiment of the invention, inflatable expandable prosthesis 202 isplaced around plug 402 and tube 204 such that tube 204 and plug 402extend into a cavity proscribed by prosthesis 202. Prosthesis 202 isattached to an exterior surface of rigid ring 412 such that air and/orother fluid injected into prosthesis 202 does not escape via theintersection of prosthesis 202 and rigid ring 412, in an embodiment ofthe invention. Optionally, a thermal method is used to attach prosthesis202 to rigid ring 412.

FIG. 5 shows an assembly 500 including a portion 502 of inflation device200 and a portion 504 of expandable prosthesis 202 further comprising acounterforce ring 506, in accordance with an exemplary embodiment of theinvention. In an embodiment of the invention, counterforce ring 506 isadapted to apply counterforce to rigid ring 412 during separation ofprosthesis inflation device 200 from prosthesis 202, as described inmore detail below with respect to FIG. 7. In some embodiments of theinvention, counterforce ring 506 is constructed of a biocompatiblematerial, for example stainless steel and/or plastic, that isapproximately at least as hard as rigid ring 412.

In some embodiments of the invention, at least one unidirectional valve600, shown in FIG. 6, is used in addition to or alternatively to plug402 and rigid ring 412 for sealing prosthesis 202 after at leastpartially inflating prosthesis 202 with prosthesis implantation and/orinflation device 200.

FIG. 3 shows an anatomical view of a human shoulder 300 with anexpandable prosthesis 100, 202 in vivo, in accordance with an exemplaryembodiment of the invention. Prosthesis 100, 202 is inserted between theacromion 302 and the coracoid process 304, in an embodiment of theinvention. In some embodiments of the invention, prosthesis 100, 202 andany other prosthesis described herein, is inserted proximal to the bursa306. Optionally, if there is no bursa 306 of any remarkable size, theprosthesis is inserted in lieu of bursa 306. In an embodiment of theinvention, an implanted prosthesis, such as those described herein, isadapted to cover the humerus head during shoulder 300 motion, whileremaining relatively fixed in relation to the acromion 302 and/or thecoracoid process 304.

In some embodiments of the invention, an anchoring expandable prosthesisis adapted to prevent and/or reduce injury to the rotator cuff and/or topermit relatively unhindered or free shoulder movement. The anchoringexpandable prosthesis comprises an expandable member and at least oneanchoring device which is adapted to be attached to a part of thepatient, for example the humerus head/tendons, acromion and/or coracoidprocess, thereby anchoring the prosthesis in place. In an embodiment ofthe invention, the anchoring expandable prosthesis comprises at leastone anchoring device attached to an expandable portion adapted tooperate similarly to prostheses 100, 202. The at least one anchoringdevice is manufactured of biocompatible and/or biodegradable ornon-biodegradable metals and/or alloys and/or composites, for exampletitanium, stainless steel or magnesium alloys. In an embodiment of theinvention, the expandable portion is manufactured of biocompatibleand/or biodegradable or non-biodegradable materials such as high densitypolyethylene or those described with respect to prostheses 100, 202. Inan embodiment of the invention, the at least one anchoring device isattached to the expandable member using filaments and/or wires.

In some embodiments of the invention, prostheses described herein areadapted for anchoring, for example by contouring the outer surface suchthat surrounding tissues can be placed within the contours, thereby“anchoring” the device. In some embodiments of the invention, thecontours are adapted to act as counterparts to anatomical features atthe implantation site, whereby the features settle into the contoursupon implantation, but still permit relatively unhindered movement ofthe treated area.

Prostheses 100, 202, and/or any of the other prostheses describedherein, are adapted for use in places where there is sliding of softtissues, such as tendons against other tissues, such as bones as: a)between the quadriceps and femur after operations on the knee, b) nearthe finger flexor and/or extensor to prevent adhesions, for treatment ofailments such as carpal tunnel syndrome or, c) between the skin andplantar fascia and calcaneus in case of calcaneal spur, in someexemplary embodiments of the invention. As described above, theprosthesis used for treatment of particular ailments is sized and/orshaped to simulate the natural bursa found at the location beingtreated, in an exemplary embodiment of the invention.

In an embodiment of the invention, an expandable prosthesis which isleast slightly elastic, but not inflatable, is adapted to prevent and/orreduce injury to the rotator cuff and/or to permit relatively unhinderedor free shoulder movement. In some embodiments of the invention, theelastic prosthesis is manufactured from polyethylene and/or siliconand/or in combination with metals, such as titanium. Optionally, theelastic prosthesis is contoured to serve as a counterpart to thesurfaces with which it will come into contact. For example in the caseof a rotator cuff, the elastic prosthesis may be contoured to fit atleast the acromion.

In an embodiment of the invention, a prosthesis is provided which issubstantially rigid. The rigid prosthesis is constructed of abiocompatible material, for example stainless steel and/or a hardplastic, in some embodiments of the invention. Optionally, the rigidprosthesis is also biodegradable. In some embodiments of the invention,the rigid prosthesis is adapted to act as a counterpart to at least oneanatomical feature at the implantation site, whereby the feature mateswith the rigid prosthesis upon implantation, but still permitsrelatively unhindered movement of the treated area. As an example, therigid prosthesis is adapted to mate with both the humerus head and theacromion upon implantation, in an embodiment of the invention.

Referring to FIG. 7, a method 700 of implanting an expandable prosthesis100, 202, or any other prosthesis described herein is described, in someexemplary embodiments of the invention. In an embodiment of theinvention, implantation method 700 is adapted for implantation ofprostheses 100, 202, or any other prosthesis described herein, into theshoulder of a patient to prevent and/or reduce injury to the rotatorcuff and/or to permit relatively unhindered or free shoulder movement.In an embodiment of the invention, prostheses 100, 202, or any otherprosthesis described herein, are introduced percutaneously or by making(702) a small incision, optionally performed by posterior, lateral oranterior approaches using, for example, palpation, arthroscopy,ultrasound (“US”), computed tomography (“CT”), magnetic resonanceimaging (“MRI”), fluoroscopy, transmission scan (“TX”), or anycombination thereof. In an embodiment of the invention, a needle isinserted (704) into the space between the rotator cuff tendons and theacromion 302 and coracoid process 304. A guide wire is introduced (706)via the needle into the space between the rotator cuff tendons and theacromion 302 and coracoid process 304, in an exemplary embodiment of theinvention. In some embodiments of the invention, a dilator is placed(708) over the guide wire and extended into the space. Subsequently, atrocar of the dilator is removed (710), leaving a dilator sheath inplace.

In an embodiment of the invention, inflatable expandable prosthesis 202is placed (712) into the space using the dilator sheath and/or theprosthesis inflation device 200 for guidance and/or movement impetus.Once prosthesis 202 is approximately in the proper position, the dilatorsheath and an external sheath 802 of prosthesis inflation device 200,shown and described in more detail with respect to FIG. 8, are withdrawn(714) to allow for inflation (716) of prosthesis 202. Inflation (716)using prosthesis inflation device 200 is described in more detail below.Inflation (716) of prosthesis 202 is achieved, in some embodiments ofthe invention, during arthroscopy. In some embodiments of the invention,for example if prosthesis 202 is implanted during open surgery orarthroscopy, proper deployment of prosthesis 202 is ascertained byvisual inspection of prosthesis 202. In an embodiment using arthroscopy,prosthesis may be introduced through an arthroscopy port. In someembodiments of the invention, inflation (716) is achieved usingpalpation and US guidance to ascertain proper deployment of prosthesis202. In some embodiments of the invention, inflation (716) is achievedusing fluoroscopy to ascertain proper deployment of prosthesis 202.Proper deployment of prostheses, in some embodiments of the invention,means no interposition of tendons and/or other soft tissue between theimplanted prosthesis and acromion 302 or coracoid process 304 and/orthat during movement of the humerus, the prosthesis remains belowacromion 302.

Inflation (716) of prosthesis 202 is performed using prosthesisinflation device 200, in an embodiment of the invention. It should beunderstood that only a portion of prosthesis inflation device 200 isshown in FIG. 2, and that exemplary variations are shown in more detailwith respect to FIGS. 16-17. Referring to FIG. 8, an expandableprosthesis 202 is shown packed for implantation and prior to deployment,in accordance with an exemplary embodiment of the invention. Componentsof the assembly 800 are enclosed in an external sheath 802 whichsurrounds at least prosthesis 202, in an exemplary embodiment of theinvention. External sheath 802 is adapted to maintain prosthesis 202 ina collapsed condition during placing (712) in order to ease insertion ofprosthesis 202 into the implantation space or site through the dilatorsheath, in an embodiment of the invention. As described above, onceprosthesis 202 is in the implantation space, external sheath 802 isremoved, enabling prosthesis 202 to be inflated without hindrance apartfrom the body parts against which prosthesis 202 is pressing.

In an embodiment of the invention, inflation (716) of prosthesis 202 isperformed using a physiologic fluid such as saline, Hartman or Ringersolutions and/or any other biocompatible and/or biodegradable fluid. Insome embodiments of the invention, inflation (716) is performed using abiocompatible and/or biodegradable gel. In an embodiment of theinvention, inflation (716) of prosthesis 202 is performed using a gas,for example air and/or carbon dioxide. In some embodiments of theinvention, the inflating gel and/or fluid contains pharmaceuticalagents, for example anti-inflammatory drugs and/or antibiotics and/orpro-angiogenesis factors to promote healing, which are eluted into thepatient's body. In some embodiments of the invention, prosthesis 202 isinflated to the maximum volume possible without reducing the shoulder'srange of movement. In an embodiment of the invention, prosthesis 202 isfilled to less than its maximum volume in order to permit shifting ofthe contents of prosthesis 202 during movement. Optionally, prosthesis202 is filled to 60%-70% of its maximum volume (for example, anexpandable member with a 14cc volume is filled with 9 cc of filler). Itshould be noted that other prosthesis embodiments described herein aredeployed in a similar fashion, in some embodiments of the invention.

Sealing (718) of prosthesis 202, once inflated to the desired level, isperformed by pulling tube 204 towards rigid ring 412 as they slide inrelation to one another plug 402 becomes lodged in a lumen 804 of rigidring 412 and continued pulling brings rigid ring 412 into contact withcounterforce ring 506, in an embodiment of the invention. In anembodiment of the invention, tube 204 passes through lumen 804 withlumen 804 providing fluid communication between prosthesis implantationand/or inflation device 200 and an inner space defined by the dimensionsof prosthesis 202. In an embodiment of the invention, an attendingmedical professional performing the implantation procedure holdscounterforce ring 506 substantially steady while pulling on tube 204away from the patient. Optionally, prosthesis inflation device 200 isadapted to perform the steadying of counterforce ring 506 and/orretraction of tube 204 automatically. In some embodiments of theinvention, a mechanism is provided to prosthesis inflation device 200which translates rotational movement to a retracting force on tube 204.Optionally, rotation movement is applied manually.

Continued pulling (“retraction” away from patient) of tube 204 causes aportion of plug 402 to break off, the portion of plug 402 lodging itselfin lumen 804 of rigid ring 412 thereby sealing prosthesis 202. In someembodiments of the invention, the portion of plug 402 becomes partiallydeformed as it lodges in lumen 804. Prosthesis inflation device 200, nowbeing separated from prosthesis 202 as a result of sealing (718) iswithdrawn (720) from the patient and patient is closed, in an exemplaryembodiment of the invention. It should be understood that in someembodiments of the invention, a sponge-like expandable prosthesis deviceis used and therefore, inflation (716) and inflation related actions maynot be carried out, for example prosthesis 100 expands rather thaninflates.

In an exemplary embodiment of the invention, the implanted prosthesis issecured, using methods known in the art, to soft tissue and/or bone toprevent the prosthesis from being easily displaced by shoulder movement.In some embodiments of the invention, sutures, clips and/or anchors areused to secure the prosthesis in place. Optionally, an anchoringexpandable prosthesis is used. In an embodiment of the invention,simulating a naturally occurring bursa using a prosthesis is an actiontaken with respect to method 700. Optionally, simulating is related toinflation (716) in that the prosthesis is inflated to resemble theappropriate size and/or shape and/or characteristics (malleability,compressibility, etc.) of the naturally occurring bursa. In anembodiment of the invention, placing the prosthesis at the implantationsite and simulating a naturally occurring bursa does not significantlyreduce movement of the soft tissues being protected in relation to theother tissues at the implantation site.

In an exemplary embodiment of the invention, prosthesis 100 is implantedby placing prosthesis 100 into a cannula, such as those describedelsewhere herein, and advancing it to the implantation site using aplunger.

In an exemplary embodiment of the invention, prosthesis 100 or theelastic prosthesis, described above, is implanted by inserting thedevice directly through a small incision, without a cannula, near theimplantation site.

It should be noted that the method shown and described with respect toFIG. 7 is by way of example only, and that similar methods could be usedfor implantation of any bursa simulating prosthesis adapted for reducinginjuries between soft tissues and other tissues of the body.

Referring to FIG. 9, a cutaway side view of a portion of a prosthesisimplantation and/or inflation device 900 and an expandable prosthesis902 for alignment of bone fragments in the case of fractures of tubularbones is shown, in accordance with an exemplary embodiment of theinvention. Prosthesis 902 is adapted to fit in the medullar cavity ofthe bone in which it is intended to be used and is optionallybiodegradable and/or biocompatible. In an embodiment of the invention,prosthesis 902 is intended to be used in non-weight bearing bones, forexample, the humerus, radius, and ulna. Prosthesis 902 comprises aninflatable tubular member 904 which is generally shaped to fit within amedullar cavity of the bones to be aligned. Optionally, inflatabletubular member 904 is tubular or vasiform. Optionally, inflatabletubular member 904 is slightly curved. In an embodiment of theinvention, inflatable tubular member 904 has an approximate outerdiameter ranging between 2 to 15 mm and having an approximate lengthranging between 5 to 50 cm. Optionally, the outer diameter rangesbetween 4 to 10 mm Optionally, the length ranges between 10 and 30 cm.In an embodiment of the invention, prosthesis 902 is sized and/or shapedto fit into the medullar cavities of the bone fragments which areintended to be aligned.

Prosthesis 902 is releasably attached to prosthesis implantation and/orinflation device 900 and/or inflated in a similar fashion as describedwith respect to prosthesis 202 and implantation and/or inflation device200, in an embodiment of the invention.

At least part of prosthesis 902 (e.g. tubular member 904) ismanufactured, in an embodiment of the invention, by dip molding.Optionally, inflatable tubular member 904 is a seamless balloon madefrom biocompatible and/or biodegradable synthetic materials such as, butnot limited to, PLA, PLGA, PCL, PDO, or any combination and/or familiesthereof. In an embodiment of the invention, inflatable tubular member904 is provided with an outer wall thickness adapted to accommodate atleast a minimum level of rigidity necessary to maintain the aligned bonefragments during normal activity. For example, forearm bones arenormally subjected to forces ranging from a few hundred grams to severalkilograms during normal activity. As another example, metacarpal bonesare normally subjected to tens of grams to a few hundred grams of force.It should be noted that these ranges are provided as examples only andthat depending on patient and/or the bone fragments being aligned, thewall thickness of inflatable tubular member will be adapted to maintainalignment of the bone fragments in spite of the anticipated stress onprosthesis 902 during normal activity and/or rehabilitation of thepatient.

In an exemplary embodiment of the invention, inflation of prosthesis 902is performed using a physiologic fluid such as saline, Hartman or Ringersolutions and/or any other biocompatible and/or biodegradable fluid. Insome embodiments of the invention, inflation is performed using abiocompatible and/or biodegradable gel. In an embodiment of theinvention, inflation of prosthesis 902 is performed using a gas, forexample air and/or carbon dioxide. In an embodiment of the invention,prosthesis 902 is filled with a cement that hardens and/or seals theopen end 906 of prosthesis 902. In some embodiments of the invention,the cement is used provide alignment for the fractured bone segments.

In an exemplary embodiment of the invention, prosthesis 902 is adaptedto elute at least one pharmaceutical agent, for exampleanti-inflammatory drugs and/or antibiotics and/or bone depositionpromoting factors and/or pro-angiogenesis factors to promote healing ofthe fracture.

In some embodiments of the invention, prosthesis 902 (and/or otherprostheses described herein) is used with a calibration kit whichdetermines the size of the medullar cavity and/or the proper sizeinflatable tubular member 904 to use with the medullar cavity.Optionally, the calibration kit is integrated with prosthesis 902.Optionally, the calibration kit is integrated with prosthesisimplantation and/or inflation device 900. In an embodiment of theinvention, a calibration expandable member is first deployed into themedullar cavity to measure the cavity shape and/or size and then upondeployment of prosthesis 902, its shape and/or size is adapted to matchthe needs of the measured medullar cavity. Optionally, various sizes ofdilators are used in conjunction with the calibration expandable memberto assist with determining size.

FIG. 10 is a flowchart 1000 showing a method of aligning two or moresegments of bone, in accordance with an exemplary embodiment of theinvention. Reduction (1002) of the fracture is performed, in anexemplary embodiment of the invention, by closed reduction. The closedreduction maneuvers are performed under fluoroscopic and/or TX guidance,in some embodiments of the invention. A skin incision is performed(1004) over a first segment of bone. In an embodiment of the invention,a hole is drilled (1006) through the compact bone of one of the bonesegments near the epiphyseal plate into the medullar channel and a guidewire is introduced (1008) through this medullar channel and advanced(1010) into the medullar channel of the other segment of bone passingthrough the fracture site. When more than two fragments of bone exist,in an embodiment of the invention, the wire passes through the medullarchannels of all segments.

A calibration device comprising a sheath and an internal trocar ispassed (1012) over the wire through the medullar channels of the bonesegments, in an embodiment of the invention. The internal trocar and thewire are removed (1014) leaving inside only the external sheath of thecalibration device within the medullar channel of the bone segments, inan exemplary embodiment of the invention. Prosthesis 902 is introduced(1016) into this sheath, in an embodiment of the invention. Thecalibration device sheath and the external sheath of prosthesis 902(similar in form and function to external sheath 802) are removed (1018)in an embodiment of the invention and the unexpanded prosthesis 902remains in the medullar channels of the segments of bone.

In an embodiment of the invention, prosthesis 902 is inflated (1020) asdescribed above with a biocompatible and/or biodegradable filler and theprosthesis 902 is detached (1022) sealing prosthesis 902 under pressure.The sealing is performed using any of the previously described methodsor by any method known to those skilled in the art. In an embodiment ofthe invention, prosthesis 902 remains within the reduced bone segmentskeeping them in alignment, as shown in FIG. 11. The skin incision isclosed (1024). In some embodiments of the invention, healing of the bonefragments is accelerated by eluting pharmaceutical agents fromprosthesis 902.

In an embodiment of the invention, alignment of the bone segments ismaintained by the rigidity of prosthesis 902. In an embodiment of theinvention, the rigidity of prosthesis 902 at least partly depends on theinternal pressure of prosthesis 902, the internal pressure being atleast partly determined by the filler used and/or the percentage ofprosthesis 902 that is filled by the filler. Optionally, an externalcast is placed on the area proximal to the fracture.

FIG. 12 is a perspective view of a device 1200 for treating inflammationand/or infection, in accordance with an exemplary embodiment of theinvention. In an embodiment of the invention, device 1200 is asponge-like structure. In some embodiments of the invention, device 1200is an inflatable structure. Device 1200 is adapted to be placed at asite in the body for treating inflammation and/or infection, in anembodiment of the invention, in an embodiment of the invention.

In an exemplary embodiment of the invention, a sponge-like device 1200is manufactured of biocompatible and/or biodegradable syntheticmaterials such as, but not limited to, PLA, PLGA, PCL, PDO, or anycombination thereof. Alternatively and/or additionally and/oroptionally, it may be manufactured from biologically derivedbiodegradable materials such as collagen. Expandable sponge-like device1200 optionally contains within its cavities at least one biocompatibleand/or biodegradable gelling material, such as methyl cellulose,agarose, poly(ethylene-glycol) (“PEG”) gel and/or PLA gel, that expandswhen it comes into contact with at least one bodily fluid, for exampleby absorbing water. In an embodiment of the invention, such absorptionis partly responsible for an expansion of sponge-like device 1200 intoits intended deployed position.

As described above, in some exemplary embodiments of the invention,device 1200 comprises an inflatable structure. In an embodiment of theinvention, inflatable device 1200 is constructed of at least onebiocompatible and/or biodegradable material, such as those describedherein. In some embodiments of the invention, inflatable device 1200 isspherical or cylindrical, having a diameter of 0.5 cm to 5 cm for asphere or in the long direction (x-axis) and 0.5 cm to 4 cm in the shortdirection (y-axis) and a height (z-axis) of 0.5 mm to 20 mm. In someembodiments of the invention, device 1200 is adapted to be inserteddeflated into a patient's body through a cannula. Optionally, thecannula is a 5 mm-7 mm cannula. Optionally, device 1200 dimensions areadapted for a particular intended use.

In some exemplary embodiments, device 1200 is inflated and/or implantedas described herein with respect to prostheses 100, 202, 902. Device1200 optionally contains pharmaceutical agents, for exampleanti-inflammatory drugs and/or antibiotics and/or pro-angiogenesisfactors to promote healing, which are eluted into the body. In someembodiments of the invention, device 1200 is adapted to elutepharmaceutical agents according to a predefined schedule. Adaptation ofdevice 1200 includes construction of device 1200 using materials orcombinations of materials which degrade at a predetermined rate, therebyreleasing pharmaceutical agents contained therein at a predeterminedrate. In an exemplary embodiment of the invention, more than one device1200 is used for treating inflammation and/or infection. Optionally,each device is adapted to elute pharmaceutical agents in view of anoverall plan incorporating a plurality of devices.

In another exemplary embodiment of the invention, an expandable device,such as those described herein, is adapted to be used near anarticulation to reinforce the articular capsule. In an embodiment of theinvention, the expandable device is introduced in anterior fashion tothe shoulder articulation between the articular capsule and the deltoidand pectoralis muscle, in order to prevent recurrent dislocation of theshoulder. In another embodiment, the expandable device is introduced infront of the hip joint capsule to prevent anterior dislocation of thehip, especially in cases of congenital dysplasia of hip. In an exemplaryembodiment of the invention, the expandable device consists of ininflatable member made of biocompatible and/or biodegradable material.In some embodiments of the invention, the expandable device has adiameter of 1 cm to 7 cm in the long direction (x-axis) and 1 cm to 5 cmin the short direction (y-axis) with a height (z-axis) of 0.5 mm to 25mm. Optionally, the device has a height of 3 mm to 15 mm.

FIG. 13 shows a perspective view of a device 1300 for treating depressedfractures, for example osteoporotic fractures of the vertebra, inaccordance with an exemplary embodiment of the invention. In someexemplary embodiments of the invention, device 1300 comprises at leasttwo separately expandable sections, an inner section 1302 and an outersection 1304. In an embodiment of the invention, at least one expandablesection is inflatable. In some embodiments of the invention, innersection 1302 when inflated takes a cylindrical shape measuringapproximately 2 to 7 cm in diameter and 2 to 5 cm in height. Optionally,inner section 1302 is larger or smaller depending on the intended use ofdevice 1300 and/or the particular needs of the patient Inner section1302 is manufactured from materials such as polyurethane, ultra highmolecular weight polyethylene (“Spectra®”) and/or Kevlar® and/or anyreinforced material that can withstand expected pressures on device 1300as a result of the intended use, in an embodiment of the invention. Insome embodiments of the invention, inner section 1302 is manufacturedfrom a biocompatible and/or biodegradable substance such as PCL, PGA,PHB, plastarch material, PEEK, zein, PLA, PDO and PLGA, collagen, methylcellulose, or any combination and/or family members thereof.

Expandable outer section 1304 at least partially surrounds inner section1302, in an exemplary embodiment of the invention. In some embodimentsof the invention, external section is a sponge-like structure, forexample like other sponge-like structures described herein. Optionally,outer section 1304 is an inflatable structure, for example like otherinflatable structures described herein. In some exemplary embodiments ofthe invention, outer section 1304 resembles a hollow cylinder, wheeland/or torus. In some embodiments of the invention, outer section 1304is made of a biocompatible and/or biodegradable material, such as thosedescribed herein and known to those in the art.

In an embodiment of the invention, inner section 1302 and outer section1304 are operatively connected to separate inflation devices.Optionally, only one inflation device is needed, for example if outersection 1304 or internal section 1302 is a sponge-like structure. Insome exemplary embodiments of the invention, components of device 1300are removably attached to at least one inflation device such asdescribed elsewhere herein.

FIG. 14 is a perspective view, with a cutaway side view of two vertebrae1402, 1404, of a device 1300 for treating depressed fractures of avertebra in vivo, in accordance with an embodiment of the invention. Insome embodiments of the invention, device 1300 is adapted to treatosteoporotic fractures of vertebrae. As described below, device 1300 isused to deploy a filler, for example cement, to act as a force forrestoring the natural shape of the fractured vertebra, thereby relievingpain and restoring at least a modicum of function to the patient.

FIG. 15 is a flowchart 1500 showing a method of treating depressedfractures, in accordance with an exemplary embodiment of the invention.In an exemplary embodiment of the invention, device 1300 is introduced(1502) to an implantation area using fluoroscopic, CT, MRI and/or TXguidance. Using a cannula, device 1300 is passed (1504) into vertebra1402 whereby the depressed fracture is concave in relation to theimplantation area, in an embodiment of the invention. An external sheath(similar in form and function of external sheath 802) of device 1300 isremoved (1506) and inner section 1302 is inflated (1508) with abiocompatible filler until the bone regains its intended shape, in anembodiment of the invention. Outer section 1304 is then inflated (1510)and internal section 1302 is deflated and optionally withdrawn (1512)from the implantation area, in an embodiment of the invention. In anembodiment of the invention, the bone whose fracture has been reduced isreinforced by filling (1514) the cavity left in external section 1304 byoptional withdrawal (1512) and/or deflation of inner section 1302 withat least one biocompatible and/or biodegradable filler, for example acement. In an exemplary embodiment of the invention, outer section 1304is deflated (1516) and optionally removed, any implantation devicesremaining in use are removed (1518) and the patient is closed (1520).Alternatively, outer section 1304 is sealed (1522) in an inflated state,for example as described herein with respect to other embodiments, andremains in place permanently or until it biodegrades.

Referring to FIG. 16, a cutaway side view of a prosthetic inflationand/or implantation device 1600 is shown, in accordance with anexemplary embodiment of the invention. Prosthesis inflation and/orimplantation device 1600 includes a grip 1602 adapted to be grasped inone hand by a medical professional performing the implantationprocedure, in an embodiment of the invention. In some embodiments of theinvention, device 1600 includes a housing 1604 adapted to mount thereina device inflation mechanism, for example a syringe 1606 comprising atleast a canister 1608 and a plunger 1610, plunger 1610 adapted to travelwithin canister 1608 and expel filler out of canister 1608 via an outlet1612 and into tube 204, described above. In an embodiment of theinvention, syringe 1606 is adapted to hold and/or inject 5-20 cc offiller. It should be noted however, that syringe 1606 is adapted to holdand/or or inject more or less filler depending on the intendedapplication of syringe 1606 and/or needs of the patient. In someembodiments of the invention, device 1600 includes a compressionassembly 1614 adapted to apply force for at least for advancement ofplunger 1610 in canister 1608 upon activation of a trigger 1616.Additionally and/or optionally, compression assembly 1614 is adapted toapply force for retraction of plunger 1610. In some embodiments of theinvention, device 1600 is used to direct a prosthesis into animplantation site, as the prosthesis is removably connected to device1600 via tube 204.

Referring to FIG. 17, a cutaway side view of an alternate prostheticinflation and/or implantation device 1700 is shown, in accordance withan exemplary embodiment of the invention. In contrast to device 1600,which advances and/or retracts plunger 1610, device 1700 is adapted toadvance and/or retract a canister 1702 portion of a syringe 1704 with aplunger 1706 portion remaining relatively fixed in relation to device1700. Plunger 1706 portion is provided with counterforce, as canister1702 portion is moved towards a proximal end 1708 of device 1700, by abackstop 1710, in an embodiment of the invention. Backstop 1710, in someexemplary embodiments of the invention, is fixed to device 1700. In anembodiment of the invention, the placement of the backstop is accordingto a predetermined level of desired inflation of the prosthesis.

In an embodiment of the invention, device 1700 is provided with a safety1712 at least to prevent over-inflation of a prosthesis attachedthereto. Safety 1712 in some embodiments of the invention, is comprisedof a ball 1714 and a spring 1716 whereby ball 1714 and backstop 1710 areadapted to be counterparts such that ball 1714 releasably fits into agroove on backstop 1710 shaped to receive ball 1714. In an embodiment ofthe invention, once canister 1702 is advanced maximally by depressing atrigger 1718, further force on trigger 1718 will cause safety 1712 todisengage backstop 1710 as a result of ball 1714 popping out of thegroove on backstop 1710 as backstop 1710 moves towards proximal end 1708under the effect of further force. It should be noted that once safety1712 has disengaged backstop 1710 and therefore, syringe 1704 is nolonger being provided with a counterforce, continued depressing oftrigger 1718 results in at least a partial retraction of tube 204 andappurtenant parts. In an embodiment of the invention, device 1700 isadapted to be used by one hand of an attending medical professional.

The present invention has been described using detailed descriptions ofembodiments thereof that are provided by way of example and are notintended to limit the scope of the invention. The described embodimentscomprise different features, not all of which are required in allembodiments of the invention. Some embodiments of the present inventionutilize only some of the features or possible combinations of thefeatures. Variations of embodiments of the present invention that aredescribed and embodiments of the present invention comprising differentcombinations of features noted in the described embodiments will occurto persons of the art. When used in the following claims, the terms“comprises”, “includes”, “have” and their conjugates mean “including butnot limited to”. The scope of the invention is limited only by thefollowing claims.

1. A shoulder implant for simulating a naturally occurring bursaproximal to or in lieu of a subacromial bursa, the shoulder implantcomprising: an expandable collagen member expandable to at least one ofa size and a shape sufficient to fill a space beneath at least one of anacromion and a coracoid process of the shoulder, wherein the expandablecollagen member is seamless and defines a cavity having an orifice, andwherein the cavity, when filled, defines a filled volume of theexpandable collagen member less than a maximal volume occupied by theexpandable collagen member; and a ring adapted to be positioned in theorifice and remain attached to the expandable member after inflation ofthe expandable member, wherein the ring defines a lumen; a collagen plugadapted to detach from an implantation or inflation device and lodge inthe lumen, thereby sealing the cavity, wherein, when implanted, theexpandable collagen member is configured to cushion and facilitatemotion between at least one of a tendon and a ligament of a rotatorcuff, and a bone part in the shoulder.
 2. The shoulder implant of claim1, wherein the expandable collagen member is inflatable with a filler tothe filled volume.
 3. The shoulder implant of claim 1, wherein theexpandable collagen member is adapted to be deflated to the filledvolume by removing some of the filler from the expandable collagenmember.
 4. The shoulder implant of claim 1, wherein the expandablecollagen member is expandable from a circular shape or an oval shape toa cylindrical shape or an ovoid shape, respectively, having the filledvolume.
 5. The shoulder implant of claim 1, further comprising ananchoring device adapted to be attached to one or more of; a humerushead, the tendon, and the at least one of the acromion and the coracoidprocess in the shoulder, thereby anchoring the shoulder implant inplace.
 6. The shoulder implant of claim 1, wherein the expandablecollagen member having the filled volume is configured to contour to anouter surface of surrounding tissues, such that the surrounding tissuesare placed within contours thereof, thereby anchoring the expandablecollagen member in place.
 7. The shoulder implant of claim 1, furthercomprising a filler, wherein the filler comprises saline, Hartmansolution, Ringer solution, gel, gas, pharmaceutical agent, and abiodegradable fluid, or any combination thereof.
 8. The shoulder implantof claim 1, wherein the filled volume is about 70% or less than themaximal volume.
 9. The shoulder implant of claim 1, wherein the filledvolume of the expandable collagen member is at least one of a size and ashape configured to resemble characteristics of at least one ofmalleability and compressibility of the naturally occurring bursa.
 10. Aprosthesis comprising: an inflatable collagen chamber defining anopening through which fluid can flow into the inflatable collagenchamber to fill the inflatable collagen chamber and defining a singlecavity comprising an outer surface having one or more external featuresconfigured to facilitate engagement between the outer surface of thesingle cavity and one or both of a first tissue and a second tissueopposite the first tissue; a rigid ring defining a lumen coupled to theopening of the inflatable collagen chamber; and a pressure regulatingvalve configured to seat in the lumen of the rigid ring to seal theopening of the collagen inflatable chamber, wherein the rigid ring isslidably disposed about a tube interfacing with the collagen inflatablechamber in a manner to prevent fluid from passing through an interfacebetween the rigid ring and the tube, wherein the prosthesis isconfigured to be positioned in a void space of a joint between the firsttissue and the second tissue, and wherein the inflatable collagenchamber deforms under pressure in response to articulation of the joint.11. The prosthesis of claim 10, wherein the rigid ring is made ofcollagen.
 12. A method comprising: (a) providing a prosthesis comprisinga collagen implant capable of deformation under pressure, the collagenimplant including a collagen rigid ring and a lumen therein for enablingfilling of the collagen implant; (b) inserting the collagen implant in avoid space in a joint; (c) inflating the collagen implant by adding afirst amount of a filler to the collagen implant, wherein the firstamount of the filler is X; (d) articulating the joint; (e) releasing asecond amount of the filler from the collagen implant through a pressureregulating valve based on a predetermined pressure in the implant,wherein the second amount of the filler released from the implant is Y,and, after the releasing, neutralizing, deactivating or removing thepressure regulating valve; and (f) sealing the collagen implant afterreleasing the second amount of the filler, wherein X is greater than Yand wherein sealing the collagen implant includes sliding a collagenplug into the lumen.
 13. The method of claim 12, wherein step (d) andstep (e) occur concomitantly.
 14. The method of claim 12, wherein thecollagen implant comprises a first face and an opposing second face,wherein step (d) further comprises articulating the joint to result in apredetermined distance between the first face of the collagen implantand the opposing second face of the implant, wherein the predetermineddistance between the first face of the collagen implant and the opposingsecond face of the collagen implant is greater than 0 millimeters. 15.The method of claim 12, wherein the ratio of X:Y is less than or equalto 4:1.
 16. The method of claim 12, wherein the ratio of X:Y is lessthan or equal to 2:1.
 17. The method of claim 12, wherein the jointcomprises a shoulder joint.